New tests aim to outsmart superbug gonorrhea
NCT ID NCT06815536
First seen Jun 24, 2026 · Last updated Sep 04, 2026 · Updated 4 times
Summary
This study is testing three new diagnostic tests to see if they can correctly identify a gene mutation that makes gonorrhea resistant to the antibiotic ciprofloxacin. Researchers will use leftover samples from over 3,000 people who already tested positive for gonorrhea. If the tests work well, they could help doctors choose the right treatment faster.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Investigational reflex tests (diagnostic tests)
- What this could lead to
- If successful, these tests could help doctors quickly tell if a gonorrhea infection is resistant to ciprofloxacin, allowing them to prescribe the right antibiotic sooner.
- What could go wrong
- This is an early-stage diagnostic study, not a treatment trial. The tests may not be accurate enough in real-world settings, and results may not change patient outcomes directly.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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2,627 people
The number who actually took part.
- Started
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Apr 2025
- Finished
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Jul 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Clinical specimens from male and females that test positive for Neisseria gonorrhoeae
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Be N. gonorrhoeae-positive on an FDA-cleared molecular assay * Have sufficient N. gonorrhoeae-positive specimen volume for testing using the corresponding investigational reflex test and genetic sequencing * Undergo proper handling and storage conditions Exclusion Criteria: * The N. gonorrhoeae-positive specimen media is not compatible with the investigational reflex test(s) at the laboratory site * The N. gonorrhoeae-positive specimen is not clearly labeled by the laboratory to link to basic epidemiologic data (age, sex) and source
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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ARUP Laboratories
Salt Lake City, Utah, 84108, United States
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Corewell Health
Royal Oak, Missouri, 48073, United States
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Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
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LabCorp
Durham, North Carolina, 27703, United States
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Mississippi State Department of Public Health
Jackson, Mississippi, 39216, United States
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Molecular Testing Labs
Vancouver, Washington, 98684, United States
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San Francisco Public Health Laboratory
San Francisco, California, 94102, United States
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University of Virginia School of Medicine
Charlottesville, Virginia, 22908, United States
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